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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038793
Receipt No. R000044227
Scientific Title Saccadic eye movement speed of an orbital floor fracture
Date of disclosure of the study information 2019/12/05
Last modified on 2019/12/04

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Basic information
Public title Saccadic eye movement speed of an orbital floor fracture
Acronym Saccadic eye movement speed of an orbital floor fracture
Scientific Title Saccadic eye movement speed of an orbital floor fracture
Scientific Title:Acronym Saccadic eye movement speed of an orbital floor fracture
Region
Japan

Condition
Condition blowout fracture
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of ocular movement disorder in patients with blow out fracture (BOF) have been conducted using HESS red-green screen test (HESS). Though HESS tracks a fixed point slowly and evaluates the deviation, it does not capture the actual movement. We focused on eye movements, specifically saccadic eye movements, and analyzed ocular movement disorder in patients with BOF.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes saccadic eye movementsin patients with blowout fracture.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
7 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria The subjects were patients with an blowout fracture who visited the Showa University Hospital East Branch from July 2016 to July 2017. The study was conducted with the approval of the Showa University Ethics Committee.
Key exclusion criteria Saccadic eye movement speed measurement date exceeding 30 days from the day of injury, surgery, oculocardiac reflex, white-eyed blowout fracture, and early enophthalmos-/hypoglobus-induced facial asymmetry.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name kota
Middle name
Last name yokoyama
Organization Showa University School of Medicine
Division name Department of Ophthalmology
Zip code 142-8555
Address 1-5-8 hatanodai Shinagawa-ku, Tokyo
TEL 03-3784-8000
Email k-yokoyama@med.showa-u.ac.jp

Public contact
Name of contact person
1st name kota
Middle name
Last name yokoyama
Organization Showa University School of Medicine
Division name Department of Ophthalmology
Zip code 142-8555
Address 1-5-8 hatanodai Shinagawa-ku, Tokyo
TEL 03-3784-8000
Homepage URL
Email k-yokoyama@med.showa-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Showa University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Showa University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa University Ethics Committee
Address 1-5-8 hatanodai Shinagawa-ku, Tokyo
Tel 03-3784-8129
Email gakuji@ofc.showa-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 昭和大学病院附属東病院(東京都)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 67
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2016 Year 07 Month 20 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Quantitative measurement of the saccadic eye movement speed in normal people(40 people 80 eyes) and patients with BOF(27 patients 27 eyes) used a visual stimulus preparation device (ViSaGe MK 2) combined with an eye tracking device (ViewPoint Eye Tracker).

Management information
Registered date
2019 Year 12 Month 04 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044227

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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